Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia

This study has been completed.
Schering Nordiska AB
Information provided by:
Karolinska University Hospital Identifier:
First received: September 8, 2005
Last updated: July 23, 2007
Last verified: August 2005

This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).

Condition Intervention Phase
Drug: alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Karolinska University Hospital:

Estimated Enrollment: 20
Study Start Date: April 2003
Study Completion Date: July 2006

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • B-CLL that has failed fludarabine

Exclusion Criteria:

  • Performance status grade 3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00162851

Dept. of Hematology, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Karolinska University Hospital
Schering Nordiska AB
Principal Investigator: Anders C Osterborg, Professor Dept. of Hematology, Karolinska University Hospital
  More Information

No publications provided Identifier: NCT00162851     History of Changes
Other Study ID Numbers: CAM219
Study First Received: September 8, 2005
Last Updated: July 23, 2007
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 06, 2015